Chinara Mambetalieva, Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission, spoke about improving the law of the Eurasian Economic Union to ensure the transition to a common market for medicines and the tools of interaction between the EAEU countries within this market at the research-to-practice conference Regulatory Practice and Registration of Medicines — RegLek 2024 held in Moscow.
At the plenary session of the conference Chinara Mambetalieva noted that December 2024 would mark the 10th anniversary of signing the Agreement on Common Principles and Rules for Regulating the Circulation of Medicines.
In the last two years, there has been an increase in the number of applications and registration certificates issued in accordance with the EAEU registration rules. Pharmaceutical inspections and issuance of GMP certificates are also progressing at a good pace.
This year, the registration rules were simplified, including a streamlined procedure for making changes to marketing authorization applications. The need to perform expert examinations when making notification-type changes has been eliminated.
Now a draft is being developed which provides that manufacturers who have initiated the procedure of bringing their medicines into compliance with the EAEU rules before December 31, 2025 will have an additional three years during which their medicinal products can circulate in
the market under national registration certificates. This will make it possible to complete the transition to the Union segment of the market, while maintaining the possibility of circulation of medicines in the markets of the Union countries where the procedures have not yet been finalized.
The emphasis was placed on the importance of existing mechanisms and tools of interaction between authorized bodies of the EAEU states and with representatives of pharmaceutical business. Information resources were presented, facilitating the functioning of the common market of medicines and uniform practical applications.
It was noted that in 2024 there has been a lot of work at the Commission to update and improve the acts in the field of regulating the common market of medicines.
